The Vendor Audit (VA) requirement sprung to life in the aircraft industry, in the late 1950’s, when it became very apparent that you could not just build an aircraft, and then certify it fit-to-fly; just by inspecting it. Quality had to be built into every manufactured part and every construction process. Opinions were out and documented company approved practices and procedures were in. Quality Management was born, not an event - a process - a mindset and a step change. Years later the same problem became apparent to the medical regulators, and cGMP appeared. The inspection and assessment of quality became extremely important, and assessing your suppliers became mandatory. Documents such as IQ,- OQ, - DQ, - PQ,- VRA,- VP, - URS, were born.
When you completed your last quality audit - just how important did you consider your documentation to be? Just how clearly was the justification for your final decision on the client's cGMP compliance defined? Were you biased at all? Were all your priorities correct?
Could your decision stand up to senior management evaluation? Could it stand up to cross examination in a court of law? Are you certain that your findings are correct? All sorts of questions are asked and and allegations made when an audit goes wrong for a GMP vendor.
This why the quality of your GMP audit documentation is of paramount importance. You must always make certain that you are going to be ‘squeaky clean’, every question, and every answer and observation, needs to be clearly documented. The company priorities must be understood and integrated into the weighting of the audit documents. If you are auditing on behalf of a client, they have a right to review your completed assessment documents and agree or disagree with your verdict.
The step-by-step, systematic approach used in this audit document, makes it easy to complete the Kepner Tregoe (KT) analysis. It can be very useful where there are many potential options to consider as well as many possible unwanted effects. Built into it is the ability to minimize some of these negative effects.
Although it is offered as an unbiased decision matrix, somebody has to decide the relative importance of the various aspects of the audit, the probability of occurrence of adverse reactions and the relative significance of each of these reactions. It's difficult to believe that there won't be any bias in there whatsoever!
KT decision making sets up an outcome as well as how exactly it should be achieved. This is often problematic because the universe often has other plans! You can have one or the other, not usually both.
A quality assessment questionnaire must cover the under listed topics but it must use a method of weighting the topics in order that the really critical topics have a more significant impact on the quality assessment outcome.
This Computer Vendor Audit document should be customized using the built
in tools. The document can then be targeted to reflect your project
priorities. The fifteen chapters all contain 10 questions, the total
scored is then weighted to reflect your priorities. By assessing the
importance of each of the chapter subjects in your project, the
weighting is altered taking points from one and adding to others. This
enables your assessment to be expressed simple and clearly as a
percentage, allowing clear unambiguous comparisons to be presented for
This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.